Fruquintinib + Tislelizumab for Colorectal Cancer

Overseen By Arvind Dasari, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids, CYP3A inducers, others

Disqualifiers: Autoimmune diseases, Cardiovascular disorders, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of two drugs, fruquintinib (a targeted therapy) and tislelizumab (an immunotherapy), can control colorectal cancer in patients showing signs of remaining cancer after standard treatments. It specifically targets individuals who have completed typical cancer treatments but still show evidence of minimal residual disease (tiny amounts of cancer that may remain) through a specific blood test. Ideal candidates have colorectal cancer confirmed by a doctor, have finished certain chemotherapy treatments, and have a positive test indicating minimal residual disease, but no visible signs of cancer on scans. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had systemic anti-cancer therapies or investigational treatments within 4 weeks before starting the trial, and certain medications like strong inducers of CYP3A should not be taken within 2 weeks before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of fruquintinib and tislelizumab is generally well-tolerated by patients. Studies have found this combination beneficial, especially when standard treatments have failed. The safety profile is considered acceptable, with manageable side effects. For example, one study found this combination effective and safe for patients with metastatic colorectal cancer, even after other treatments had failed. While no treatment is without risk, current data suggest that patients often handle this combination treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Fruquintinib and Tislelizumab for colorectal cancer because they bring a novel approach to tackling the disease. Fruquintinib is a targeted therapy that inhibits blood vessel growth in tumors, potentially starving the cancer cells. Tislelizumab, on the other hand, is a type of immunotherapy that helps the body's immune system recognize and attack cancer cells more effectively. Together, these treatments offer a unique one-two punch by both directly inhibiting tumor growth and enhancing the immune response. This combination could provide a new avenue for patients, especially those who may not respond well to traditional chemotherapy.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that combining fruquintinib and tislelizumab may help treat colorectal cancer. In a study with patients who had already tried standard treatments, this combination proved beneficial. Participants in this trial will receive both fruquintinib and tislelizumab as part of the treatment regimen. For those with advanced colorectal cancer, fruquintinib is recommended after other treatments. Additionally, using these drugs together has yielded good results for patients who did not improve with other therapies. Overall, early research suggests this combination could effectively manage the disease. ^{2 3 4 5 6}

Who Is on the Research Team?

Arvind Dasari, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've finished treatment for stages II-IV colorectal cancer, including ≥3 months of specific chemotherapy. They must show no signs of cancer on scans but have positive ctDNA tests indicating minimal residual disease. Participants need good organ function and performance status, agree to use contraception, and not have other serious health issues or recent treatments that could interfere.

Inclusion Criteria

I completed treatment for stage II-IV colorectal cancer, including over 3 months of chemotherapy with oxaliplatin.

Is able to understand and is willing to sign a written informed consent document

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Prior allogeneic stem cell transplantation or organ transplantation

Any of the following cardiovascular risk factors: Acute myocardial infarction ≤6 months before the first dose of study drug(s), Heart failure meeting New York Heart Association Function Classification III or IV ≤6 months before the first dose of study drug(s), Ventricular arrhythmia Grade ≥2 in severity ≤6 months before the first dose of study drug(s), Cerebrovascular accident ≤12 months before the first dose of study drug(s), Uncontrolled hypertension that cannot be managed by standard antihypertension medications, which is specified as systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg. The participant must have blood pressures below both limits. Repeated assessments are permitted, Syncope or seizure ≤28 days before the first dose of study drug(s)

Mean QT interval corrected by the method of Fridericia (QTcF) ≥480 ms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fruquintinib and Tislelizumab therapy to assess ctDNA clearance in colorectal cancer with minimal residual disease

6 months

Follow-up

Participants are monitored for safety, ctDNA clearance, disease-free survival, and overall survival after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fruquintinib
• Tislelizumab

Trial Overview The trial is testing if combining fruquintinib with tislelizumab can control colorectal cancer in patients who still show evidence of minimal residual disease through ctDNA tests after completing their initial treatment regimen.

How Is the Trial Designed?

Group I: Phase II: Treatment with Fruquintinib and Tislelizumab Experimental Treatment 2 Interventions

Treatment with Fruquintinib and Tislelizumab

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Takeda Pharmaceutical Co. Limited

Collaborator

Trials

1

Recruited

12,000+

BeiGene

Industry Sponsor

Trials

216

Recruited

32,500+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.150

Fruquintinib combined with tislelizumab and SBRT as a ... Conclusions: Fruquintinib plus tislelizumab and SBRT as a later-line therapy in refractory MSS mCRC pts shows a promising clinical benefit, with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12489717/

Efficacy and safety of fruquintinib combined with ... The global, multicenter FRESCO-2 trial demonstrated that fruquintinib significantly improved outcomes compared with the placebo, with a median ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)02664-9/fulltext

637P A phase II study to evaluate the efficacy and safety ... Fruquintinib combined with tislelizumab and HAIC showed promising efficacy and acceptable safety for CRLM pts who had failed standard therapy in this interim ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05435313

Fruquintinib Combined With Tislelizumab and HAIC in ... Fruquintinib is a small molecule angiogenesis inhibitor, and has been recommended for third-line treatment of metastatic colorectal cancer (mCRC). Tislelizumab ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20536231

Efficacy and Safety of Tislelizumab in Combination With ... The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3543

A phase II study to evaluate the efficacy and safety of ... The updated data on the survival analysis revealed that fruquintinib combined with tislelizumab and HAIC had a survival benefit in CRLM pts with MSS who had ...